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AZithromycin Against pLacebo in Exacerbations of Asthma

Information source: Imperial College London
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Zithromax (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Imperial College London

Official(s) and/or principal investigator(s):
Sebastian L Johnston, MBBS, PhD, FRCP, Study Chair, Affiliation: Imperial College London

Overall contact:
Sebastian L Johnston, Email: s.johnston@imperial.ac.uk

Summary

Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why

azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.

Clinical Details

Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients With Acute Exacerbations of Asthma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Diary card summary symptom score

Secondary outcome:

Quality of life

Time to 50% reduction in symptom score

Pulmonary Function tests

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Patients meeting all of the following criteria will be considered for admission to the study:

- Adults, either sex, ages 18-55 years or age 56 to 65 with < 20 pack year smoking

history or age >65 with <5 pack year smoking history

- Patients with a documented history of asthma for >6 consecutive months, and

- Patients presenting within 24 hours (of initial presentation to medical care) with an

acute deterioration in asthma control (increased wheeze, dyspnea and/or cough and/or reduced PEF) and requiring a course of oral steroids

- Patients with a PEF or FEV1 less than 80% of predicted normal or patient's best at

presentation, at recruitment or in the time elapsed between presentation and recruitment

- Patients must be able to complete diaries and quality of life questionnaires.

- Patients must sign and date an informed consent prior to any study procedures.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

- Smokers aged 56-65 with a >20 pack year history

- Patients requiring immediate placement in ICU

- Patients who used oral or systemic antibiotics within 28 days prior to enrolment

- Patients with known impaired hepatic function (ALT/AST > 2 ULN)

- Patients with significant lung disease (including COPD) other than asthma

- Patients with ≥ 10mg oral corticosteroid maintenance therapy

- Patients requiring other antibiotic therapy

- Patients who are receiving other medications or who have other disease conditions or

infections that could interfere with the evaluation of drug efficacy or safety

- Women who are breast-feeding or are pregnant, as demonstrated by a urine pregnancy

test carried out before exposure to study medication or the start of any study procedure that could pose a risk to the foetus

- Patients with suspected or known hypersensitivity to, or suspected serious adverse

reaction to Azithromycin or any of the macrolide or ketolide class of antibiotics, erythromycin or to any excipients thereof

- Patients who have received treatment with any other investigational drug within 1

month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase

- Patients with a concomitant condition (including clinically relevant cardiovascular,

hepatic, neurologic, endocrine, or other major systemic disease) making implementation of the protocol or interpretation of the study results difficult

- Patients with mental conditions rendering them unable to understand the nature,

scope, and possible consequences of the study.

- Patients unlikely to comply with the protocol, e. g., uncooperative attitude,

inability to return for follow-up visits.

- No subject will be allowed to enrol in this study more than once.

Locations and Contacts

Sebastian L Johnston, Email: s.johnston@imperial.ac.uk

Heart of England NHS Foundation Trust, Birmingham B9 5SS, United Kingdom; Not yet recruiting
Adel H Mansur, Email: adel.mansur@heartofengland.nhs.uk
Adel H Mansur, FRCP PhD, Principal Investigator

University of Glasgow, Glasgow G12 0YN, United Kingdom; Recruiting
Neil C Thomson, Email: n.c.thomson@clinmed.gla.ac.uk
Rekha Chaudhuri, MBBS MD MD, Email: rekha.chauhuri@ggc.scot.nhs.uk
Neil C Thomson, MBChB MD FRCP FRCP, Principal Investigator
Rekha Chaudhuri, MBBS MD MD, Principal Investigator

University Hospitals of Leicester NHS Foundation Trust, Leicester LE39QP, United Kingdom; Recruiting
Christopher E Brightling, Email: ceb17@leicester.ac.uk
Christopher E Brightling, BSc MBBS MRCP PhD FCCP, Principal Investigator

Imperial College Healthcare NHS Trust, London W2 1PG, United Kingdom; Recruiting
Sebastian L Johnston, Email: s.johnston@imperial.ac.uk
Sebastian L Johnston, MBBS PhD FRCP, Principal Investigator
Philip W Ind, BA MA MB BChir MRCP FRCP, Principal Investigator
Patrick Mallia, MD MRCP PhD, Sub-Investigator

Guy's and St Thomas' NHS Foundation Trust, London SE1 9RT, United Kingdom; Recruiting
Christopher Corrigan, Email: chris.corrigan@kcl.ac.uk
Christopher Corrigan, FRCP PhD MBBS MSc BA, Principal Investigator

University Hospital of South Manchester Foundation Trust, Manchester M23 9QZ, United Kingdom; Not yet recruiting
David Singh, Email: dsingh@meu.org.uk
Vandana Gupta, Email: vgupta@meu.org.uk
David Singh, BA MB BChir MA MRCP MD, Principal Investigator

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle NE7 7DN, United Kingdom; Recruiting
Bernard G Higgins, Email: b.g.higgins@newcastle.ac.uk
Bernard G Higgins, MBChB MRCP MD FRCP, Principal Investigator

Nottingham University Hospitals NHS Trust, Nottingham NG5 1PB, United Kingdom; Recruiting
Timothy W Harrison, Email: tim.harrison@nottingham.ac.uk
Timothy W Harrison, BSc MBBS MRCP MD MSc, Principal Investigator

Portsmouth Hospitals NHS Trust, Portsmouth PO6 3LY, United Kingdom; Recruiting
Anoop J Chauhan, MB ChB FRCP PhD, Email: anoop.chauhan@portshosp.nhs.uk
Anoop J Chauhan, MB ChB FRCP Phd, Principal Investigator

Sherwood Forest Hospitals NHS Foundation Trust, Sutton in Ashfield NG17 4JL, United Kingdom; Not yet recruiting
Michael Ward
Michael Ward, Principal Investigator

Additional Information

Starting date: September 2011
Last updated: June 14, 2012

Page last updated: February 07, 2013

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